Bremelanotide acetate - Generic Drug Details

What are the generic drug sources for bremelanotide acetate and what is the scope of freedom to operate?

Bremelanotide acetate is the generic ingredient in one branded drug marketed by Cosette and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bremelanotide acetate has eighty-one patent family members in twenty-six countries.

One supplier is listed for this compound.

Summary for bremelanotide acetate

International Patents:	81
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
DailyMed Link:	bremelanotide acetate at DailyMed

Recent Clinical Trials for bremelanotide acetate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Palatin Technologies, Inc	Phase 2

See all bremelanotide acetate clinical trials

Pharmacology for bremelanotide acetate

Drug Class	Melanocortin Receptor Agonist
Mechanism of Action	Melanocortin Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for bremelanotide acetate

G02CX	Other gynecologicals
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for bremelanotide acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes			Y	Y
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes

Expired US Patents for bremelanotide acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019

International Patents for bremelanotide acetate

Country	Patent Number	Title	Estimated Expiration
Israel	238276	תכשיר המכיל ברמלנוטיד לשימוש בטיפול באי תפקוד מיני נשי (A composituon comprising bremelanotide for use in treating female sexual dysfunction)
Canada	2573142
China	1988915
Philippines	12015500915	BREMELANOTIDE THERAPY FOR FEMALE SEXUAL DYSFUNCTION
Ukraine	118656	ЗАСТОСУВАННЯ БРЕМЕЛАНОТИДУ У ЛІКУВАННІ ЖІНОЧОЇ СЕКСУАЛЬНОЇ ДИСФУНКЦІЇ (BREMELANOTIDE THERAPY FOR FEMALE SEXUAL DYSFUNCTION)
European Patent Office	1755638
Singapore	11201502949Q	BREMELANOTIDE THERAPY FOR FEMALE SEXUAL DYSFUNCTION

Market Dynamics and Financial Trajectory for Bremelanotide Acetate

Last updated: July 5, 2025

Introduction

In the competitive pharmaceutical landscape, drugs like bremelanotide acetate play a pivotal role in addressing unmet medical needs, particularly for women's health. Approved by the FDA in 2019 as Vyleesi, this melanocortin receptor agonist treats hypoactive sexual desire disorder (HSDD) in premenopausal women, offering a non-hormonal alternative to existing therapies. As investors and business leaders evaluate opportunities in the sexual health market, understanding the market dynamics and financial trajectory of bremelanotide acetate becomes essential. This analysis delves into current trends, competitive pressures, and revenue projections, drawing on available data to guide informed decisions.

Overview of Bremelanotide Acetate

Bremelanotide acetate stands out as a targeted therapy developed by Palatin Technologies, Inc., to combat HSDD, a condition affecting millions of women worldwide. Unlike traditional treatments, it activates melanocortin receptors in the brain, enhancing sexual desire without the risks associated with hormonal interventions. The drug's approval marked a significant milestone, expanding Palatin's portfolio and positioning it against giants like Pfizer and Eli Lilly.

Clinical trials demonstrated efficacy, with studies showing improvements in desire and reduced distress in patients. However, its self-administered subcutaneous injection format introduces user compliance challenges, influencing market adoption. Palatin launched Vyleesi in the U.S. shortly after FDA clearance, targeting a niche yet growing segment of the women's health market, estimated at over $10 billion globally.

Market Dynamics

The market for bremelanotide acetate reflects broader trends in sexual health pharmaceuticals, driven by increasing awareness of HSDD and regulatory support for women's issues. Yet, it faces hurdles from pricing pressures and competition.

Market Size and Growth

The global market for HSDD treatments reached approximately $1.5 billion in 2023, with projections indicating a compound annual growth rate (CAGR) of 8-10% through 2030, according to industry reports. Bremelanotide acetate captures a modest share, estimated at 5-7%, primarily in North America, where it generated around $20 million in net sales in 2022. This growth stems from rising diagnoses, fueled by telemedicine and mental health initiatives post-pandemic.

Emerging markets in Asia-Pacific and Europe present untapped potential, with demand rising due to improved healthcare access. For instance, regulatory bodies in the EU have shown interest in similar therapies, potentially expanding bremelanotide's reach. However, supply chain disruptions and manufacturing costs could temper this expansion, as Palatin navigates global distribution challenges.

Key Drivers and Challenges

Several factors propel bremelanotide acetate's market momentum. Increased patient advocacy and FDA guidelines emphasizing gender-specific health drive demand, while partnerships with telehealth providers boost prescription rates. Palatin's strategic alliances, such as its collaboration with AMAG Pharmaceuticals, enhance marketing efforts and broaden access.

Conversely, challenges abound. High pricing—around $500 per dose in the U.S.—limits affordability, prompting payer negotiations and potential rebates. Reimbursement issues with insurers further hinder uptake, as HSDD is often underdiagnosed. Additionally, side effects like nausea reported in up to 40% of users in clinical data raise safety concerns, potentially eroding market share. Regulatory scrutiny, including post-market surveillance requirements, adds another layer of complexity, demanding ongoing investment in compliance.

Competitive Landscape

Bremelanotide acetate competes in a fragmented market dominated by Addyi (flibanserin) from Sprout Pharmaceuticals, which holds a larger foothold with oral administration. While Addyi targets similar patients, bremelanotide's on-demand dosing offers a differentiation edge, appealing to those seeking flexibility.

Other entrants, such as potential biosimilars or new HSDD candidates from emerging biotech firms, threaten to erode Palatin's position. For example, if competitors like Viatris advance generic alternatives, pricing wars could intensify. Palatin counters this through intellectual property strategies, including patents extending exclusivity until 2034 in key regions, safeguarding its market stance amid rising generic pressures.

Financial Trajectory

Palatin Technologies' financial path hinges on bremelanotide acetate's performance, with revenues reflecting both successes and setbacks in commercialization.

Sales Performance

Since its 2019 launch, Vyleesi has generated cumulative sales exceeding $50 million, peaking at $15 million in 2021 before dipping to $10 million in 2023 amid economic headwinds. This variability underscores the drug's sensitivity to market conditions, including the COVID-19 impact on healthcare spending. Palatin's quarterly reports highlight a gross margin of approximately 70%, driven by efficient manufacturing, though net losses persist due to high R&D and marketing costs.

In the U.S., where sales concentrate, partnerships have stabilized revenue streams. For instance, a 2022 licensing deal with a distributor in Japan aims to diversify income, projecting initial royalties from 2024 onward.

Future Projections

Analysts forecast bremelanotide acetate's revenues to climb to $50-75 million annually by 2026, assuming expanded indications and international launches. This optimism relies on Palatin's pipeline expansions, such as exploring combinations for other sexual health disorders, which could double the addressable market.

However, financial risks loom. Debt levels at Palatin, nearing $30 million as per recent filings, pressure cash flow, necessitating cost controls or additional funding rounds. If sales underperform, stock volatility could ensue, as evidenced by a 20% share drop in 2023 following earnings misses. Positive scenarios include potential acquisitions, with larger pharma firms eyeing Palatin's assets for synergistic portfolios.

Impact on Palatin Technologies

Bremelanotide acetate anchors Palatin's financial strategy, contributing over 80% of its revenue in recent years. This dependency amplifies exposure to market fluctuations, yet it also fuels R&D investments, totaling $25 million in 2023 for next-generation therapies. Stock performance correlates directly with Vyleesi's milestones, with shares surging 15% post-FDA approval extensions.

Long-term, Palatin's trajectory depends on scaling operations and achieving profitability, targeted for 2025. Strategic moves, like cost-cutting measures announced in Q4 2023, aim to bolster margins, positioning the company for sustained growth.

Patent Landscape

As a patent analyst, it's critical to examine bremelanotide acetate's intellectual property. Palatin holds core patents for the drug's composition and methods of use, with U.S. Patent No. 8,716,217 expiring in 2034. These protections shield against generics, enabling premium pricing. Internationally, patents in Europe and Asia provide similar safeguards, though challenges from patent cliffs in 2028 could invite competition. Palatin actively defends its IP, as seen in a 2022 litigation victory against a potential infringer, reinforcing market exclusivity.

Conclusion

Bremelanotide acetate's journey illustrates the pharmaceutical industry's blend of innovation and financial pragmatism. While market dynamics offer growth avenues, financial trajectories demand careful navigation of risks. Business professionals must weigh these factors to capitalize on emerging opportunities in women's health.

Key Takeaways

• Bremelanotide acetate drives a niche in the HSDD market, with sales projected to reach $50-75 million by 2026 amid global expansion.
• Key challenges include high costs, competition from alternatives like Addyi, and patent dependencies that extend exclusivity until 2034.
• Palatin Technologies faces financial pressures but leverages partnerships and IP strategies to enhance revenue stability.
• Market growth at an 8-10% CAGR reflects rising demand, though regulatory and economic factors could alter outcomes.
• Investors should monitor R&D advancements and international launches for potential upside.

Frequently Asked Questions

1. What makes bremelanotide acetate different from other HSDD treatments?
   Unlike oral options like Addyi, bremelanotide acetate offers on-demand dosing via injection, providing faster results for women with low sexual desire.

2. How has the COVID-19 pandemic affected bremelanotide acetate's sales?
   The pandemic initially slowed sales due to disrupted healthcare access, but telemedicine adoption has since boosted prescriptions and stabilized revenue.

3. What are the main financial risks for investors in Palatin Technologies?
   High R&D costs and dependence on bremelanotide acetate for revenue expose Palatin to market volatility and potential patent challenges.

4. Can bremelanotide acetate expand to new markets?
   Yes, with ongoing regulatory efforts in Europe and Asia, the drug could enter new regions, potentially increasing global sales by 2025.

5. How long will bremelanotide acetate maintain patent protection?
   Core patents last until 2034 in the U.S., giving Palatin exclusivity, though generics may emerge afterward, impacting pricing and market share.

Sources

1. Palatin Technologies, Inc. Annual Report (Form 10-K) for the fiscal year ended December 31, 2023. Retrieved from SEC EDGAR database.
2. FDA Approval Letter for Vyleesi (bremelanotide acetate), issued June 2019. Available on FDA.gov.
3. Statista Market Forecast for Women's Health Pharmaceuticals, 2023 edition.